Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic

INTRODUCTION: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials. Regulatory units...

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Detalhes bibliográficos
Publicado no:J Clin Transl Sci
Main Authors: Gravelin, Misty, Wright, Jeanne, Holbein, M.E. Blair, Berro, Marlene, Brown, Jennifer S., Mashour, George A., Weatherwax, Kevin J.
Formato: Artigo
Idioma:Inglês
Publicado em: Cambridge University Press 2021
Assuntos:
Research Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC8134898/
https://ncbi.nlm.nih.gov/pubmed/34192051
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1017/cts.2021.15
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